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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Taiho Pharmaceutical Co., Ltd. |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00077142 |
Purpose
RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to see how well it works in treating patients with advanced hepatocellular carcinoma (liver cancer).
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: TAC-101 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma |
| Enrollment: | 37 |
| Study Start Date: | April 2001 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TAC-101
Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.
|
Drug: TAC-101
Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.
|
OBJECTIVES:
Phase I
Primary
Phase II
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Cohorts of 6 patients receive escalating doses of TAC-101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 35-60 days.
PROJECTED ACCRUAL: A total of 6-18 patients for the phase I portion and 21-41 patients for the phase II portion will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulants
Contacts and Locations| United States, Texas | |
| MD Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Melanie B. Thomas, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Melanie Thomas, MD, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00077142 History of Changes |
| Other Study ID Numbers: | ID01-007, P30CA016672, MDA-ID-01007, TAIHO-TAC101, NCI-1528, CDR0000349508 |
| Study First Received: | February 10, 2004 |
| Last Updated: | August 19, 2010 |
| Health Authority: | United States: Federal Government |
|
advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer Oral TAC-101 |
|
Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma |